Brief Report: HIV Pre-Exposure Prophylaxis Awareness and Use Among Adolescents in Kenya.

BACKGROUND: HIV pre-exposure prophylaxis (PrEP) is an effective prevention tool; however, use among adolescents is thought to be low. To determine the unmet need and opportunity to expand use, we assessed awareness, prior use, and willingness to take PrEP among Kenyan adolescents. METHODS: The Maneno Yetu study recruited a community-based sample of adolescents aged 15-19 years (N = 3061) in Kisumu for a survey using respondent-driven sampling. RESULTS: Overall, 50% of adolescents had heard of PrEP and 2% had used PrEP. Girls were more likely than boys to have heard of PrEP (53.4% vs. 45.1%; P < 0.001) and used PrEP (3.6% vs. 0.3%; P < 0.001). Among participants, 14% engaged in transactional sex and 21% experienced forced sexual contact. PrEP use was higher among adolescents who engaged in transactional sex (4.8% vs. 0.6%; P < 0.001) and experienced forced sexual contact (2.7% vs. 0.7%; P < 0.001) compared with those who did not. Among adolescents with no prior use, 53% were willing to consider using PrEP, although girls were less willing than boys (49.7% vs. 55.9%; P = 0.001). CONCLUSIONS: PrEP is an important prevention tool, especially for adolescents whose circumstances potentially expose them to HIV-positive or unknown status sexual partners, yet remains underused, particularly in resource-limited settings. Although many expressed willingness to use PrEP, low awareness and use highlight the need to expand HIV prevention education and services tailored for adolescents. Our finding that boys were more willing to use PrEP suggests campaigns should also be designed to reach male youth to narrow the gender gap and expand uptake in the adolescent population.

Adaptive Strategies for Retention in Care among Persons Living with HIV.

BACKGROUND: Optimizing retention in human immunodeficiency virus (HIV) treatment may require sequential behavioral interventions based on patients' response. METHODS: In a sequential multiple assignment randomized trial in Kenya, we randomly assigned adults initiating HIV treatment to standard of care (SOC), Short Message Service (SMS) messages, or conditional cash transfers (CCT). Those with retention lapse (missed a clinic visit by ≥14 days) were randomly assigned again to standard-of-care outreach (SOC-Outreach), SMS+CCT, or peer navigation. Those randomly assigned to SMS or CCT who did not lapse after 1 year were randomly assigned again to either stop or continue the initial intervention. Primary outcomes were retention in care without an initial lapse, return to the clinic among those who lapsed, and time in care; secondary outcomes included adjudicated viral suppression. Average treatment effect (ATE) was calculated using targeted maximum likelihood estimation with adjustment for baseline characteristics at randomization and certain time-varying characteristics at rerandomization. RESULTS: Among 1809 participants, 79.7% of those randomly assigned to CCT (n=523/656), 71.7% to SMS (n=393/548), and 70.7% to SOC (n=428/605) were retained in care in the first year (ATE: 9.9%; 95% confidence interval [CI]: 5.4%, 14.4% and ATE: 4.2%; 95% CI: -0.7%, 9.2% for CCT and SMS compared with SOC, respectively). Among 312 participants with an initial lapse who were randomly assigned again, 69.1% who were randomly assigned to a navigator (n=76/110) returned, 69.5% randomly assigned to CCT+SMS (n=73/105) returned, and 55.7% randomly assigned to SOC-Outreach (n=54/97) returned (ATE: 14.1%; 95% CI: 0.6%, 27.6% and ATE: 11.4%; 95% CI: -2.2%, 24.9% for navigator and CCT+SMS compared with SOC-Outreach, respectively). Among participants without lapse on SMS, continuing SMS did not affect retention (n=122/180; 67.8% retained) versus stopping (n=151/209; 72.2% retained; ATE: -4.4%; 95% CI: -16.6%, 7.9%). Among participants without lapse on CCT, those continuing CCT had higher retention (n=192/230; 83.5% retained) than those stopping (n=173/287; 60.3% retained; ATE: 28.6%; 95% CI: 19.9%, 37.3%). Among 15 sequenced strategies, initial CCT, escalated to navigator if lapse occurred and continued if no lapse occurred, increased time in care (ATE: 7.2%, 95% CI: 3.7%, 10.7%) and viral suppression (ATE: 8.2%, 95% CI: 2.2%, 14.2%), the most compared with SOC throughout. Initial SMS escalated to navigator if lapse occurred, and otherwise continued, showed similar effect sizes compared with SOC throughout. CONCLUSIONS: Active interventions to prevent retention lapses followed by navigation for those who lapse and maintenance of initial intervention for those without lapse resulted in best overall retention and viral suppression among the strategies studied. Among those who remained in care, discontinuation of CCT, but not SMS, compromised retention and suppression. (Funded by National Institutes of Health grants R01 MH104123, K24 AI134413, and R01 AI074345; ClinicalTrials.gov number, NCT02338739.).

HIV Infection Among Adolescents Residing in Urban Informal Settlements of Kenya.

Adolescents comprise approximately 15% of new HIV infections in Kenya. Impoverished living conditions in informal settlements place residents at high risk for HIV infection. We assessed factors associated with HIV infection among adolescents residing in urban informal settlements in Kisumu. We recruited 3,061 adolescent boys and girls aged 15-19. HIV prevalence was 2.5% overall, all newly identified cases were among girls and infection was positively associated with not completing a secondary education (p < .001). Girls who had ever been pregnant (p < .001) or out-of-school without completing a secondary education (p < .001) were more likely to be HIV-positive. Our findings of higher HIV prevalence among adolescent girls who had been pregnant or did not complete secondary school highlight the need to facilitate access to HIV testing, HIV pre-exposure prophylaxis, and sexual and reproductive health services as components of a comprehensive prevention strategy to decrease HIV infections in this priority population.

Respondent-driven sampling to recruit adolescents in Kenya.

PURPOSE: Respondent-driven sampling (RDS) uses long-chain referral whereby members of the target population recruit other members. We describe the use of RDS for a mixed-methods sexual and reproductive health (SRH) study in Kisumu, Kenya. METHODS: Initial seeds for the cross-sectional surveys were selected from adolescents aged 15-19 residing in urban informal settlements. Participants were provided up to five referral coupons to distribute. RESULTS: Across four communities, 18 seeds were selected, 13,489 coupons distributed, and 3381 adolescents referred, yielding a 25% coupon return rate. We enrolled 3061 participants for a 23% survey rate. Median referral lag time was three days (IQR 1, 7). Demographic characteristics reached equilibrium between recruitment waves 5 to 8 in three communities, and waves 7 to 15 in the fourth. CONCLUSIONS: Our study demonstrated that RDS is a feasible and efficient approach for recruiting a large sample of adolescents. Though our research focused on SRH, many adolescents residing in the impoverished urban environments where our study was implemented also experience food insecurity, housing instability and violence. RDS can therefore be a valuable recruitment approach for future studies to reach vulnerable adolescents and design interventions that address the variety of health-related challenges that affect this underserved population.

Improvements in pediatric and adolescent HIV testing and identification in western Kenya under the Accelerating Children's HIV/AIDS Treatment initiative.

Pediatric HIV remains a significant global concern, with 160,000 new infections annually. Accelerating Children's HIV/AIDS Treatment (ACT) provided a strategic response to the "treatment gap" for children. We examined whether activities under ACT increased testing and identification of youth living with HIV (YLWH). Family AIDS Care & Education Services implemented ACT across 130 health facilities in western Kenya between October 2015 and September 2016, providing: HIV-testing counselors and space; training on the Family Information Table (FIT) and chart audits; community outreach testing; and text message reminders for pregnant women. We analyzed the number of youths tested and identified with HIV over time and between intervention and control sites using interrupted time series analysis. We tested 268,312 youths (7,183 infants <18 months; 145,833 children 18 months to 9 years; and 115,296 adolescents 10-14 years). Mean monthly number tested per health facility increased from 2.8 to 7.2 (p < 0.0001) in infants, 44.8-142.0 (p < 0.0001) in children, and 30.1-123.3 (p < 0.0001) in adolescents. Mean monthly number identified with HIV per facility increased from 0.06 to 0.37 (p < 0.0001) in infants; 0.34-0.62 (p = 0.008) in children; and 0.17-0.26 (p = 0.04) in adolescents, resulting in 1,328 diagnoses. Among infants, FIT training was associated with increased HIV testing over time, incidence rate ratio (IRR) = 3.85 (95% confidence interval [CI] 2.16-6.84; p < 0.0001). Text messaging increased testing, IRR = 2.10 (95% CI 1.57-2.80; p < 0.0001) and identification of HIV in infants, IRR = 1.83 (95% CI 1.06-3.18; p = 0.0381) and older children, IRR = 2.25 (95% CI 1.62, 3.13; p < 0.0001). Chart audits increased testing over time among adolescents (IRR = 2.11; 95% CI 1.21-3.66; p = 0.0082). Outreach was associated with identification of adolescents with HIV, IRR = 1.58 (95% CI 1.22-2.06; p = 0.0005). In lower-income settings, targeted interventions effective at reaching YLWH can help optimize resource allocation to address gaps in testing and identification to further reduce HIV-related morbidity and mortality.

Community-Based HIV Testing for Urban Youth in Western Kenya.

Youth aged 15-24 years comprise 48% of new HIV infections and 15% of persons living with HIV in Kisumu County, Kenya. We assessed factors associated with HIV infection among youth participating in the Community Health Initiative (CHI) implemented in an urban informal settlement in 2018. Predictors of HIV infection were assessed by multivariable logistic regression. CHI engaged 4,441 youth through community health campaigns and home-based HIV testing. HIV prevalence was 3.5% overall and 7.1% among young women aged 20-24. There were 24 youth newly identified as HIV-positive out of 157 total HIV-positive youth. HIV-positive status was positively associated with being female (aOR = 2.46; 95% CI 1.57, 3.84) and aged 20-24 (aOR = 2.40; 95% CI 1.52, 3.79), and inversely associated with secondary school education or higher (aOR = 0.27; 95% CI 0.16, 0.44). Our findings highlight the need for HIV prevention programs specially tailored for youth to further reduce new HIV infections in this priority population.

Implementation Science Protocol: evaluating evidence-informed interventions to improve care for people with HIV seen in Ryan White HIV/AIDS program settings.

In 2017, the Health Resources and Services Administration's HIV/AIDS Bureau funded an Evaluation Center (EC) and a Coordinating Center for Technical Assistance (CCTA) to oversee the rapid implementation of 11 evidence-informed interventions at 26 HIV care and treatment providers across the U.S. This initiative aims to address persistent gaps in HIV-related health outcomes emerging from social determinants of health that negatively impact access to and retention in care. The EC adapted the Conceptual Model of Implementation Research to develop a Hybrid Type III, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, as well as HIV-related health outcomes for clients engaged in the evidence-informed interventions. This approach will allow us to understand in detail the processes that sites undergo to implement these important intervention strategies for high priority populations.

Practice transformations to optimize the delivery of HIV primary care in community healthcare settings in the United States: A program implementation study.

BACKGROUND: The United States HIV care workforce is shrinking, which could complicate service delivery to people living with HIV (PLWH). In this study, we examined the impact of practice transformations, defined as efficiencies in structures and delivery of care, on demonstration project sites within the Workforce Capacity Building Initiative, a Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program Special Projects of National Significance (SPNS). METHODS AND FINDINGS: Data were collected at 14 demonstration project sites in 7 states and the District of Columbia. Organizational assessments were completed at sites once before and 4 times after implementation. They captured 3 transformation approaches: maximizing the HIV care workforce (efforts to increase the number of existing healthcare workforce members involved in the care of PLWH), share-the-care (team-based care giving more responsibility to midlevel providers and staff), and enhancing client engagement in primary HIV care to reduce emergency and inpatient care (e.g., care coordination). We also obtained Ryan White HIV/AIDS Program Services Reports (RSRs) from sites for calendar years (CYs) 2014-2016, corresponding to before, during, and after transformation. The RSR include data on client retention in HIV care, prescription of antiretroviral therapy (ART), and viral suppression. We used generalized estimating equation (GEE) models to analyze changes among sites implementing each practice transformation approach. The demonstration projects had a mean of 18.5 prescribing providers (SD = 23.5). They reported data on more than 13,500 clients per year (mean = 969/site, SD = 1,351). Demographic characteristics remained similar over time. In 2014, a majority of clients were male (71% versus 28% female and 0.2% transgender), with a mean age of 47 (interquartile range [IQR] 37-54). Racial/ethnic characteristics (48% African American, 31% Hispanic/Latino, 14% white) and HIV risk varied (31% men who have sex with men; 31% heterosexual men and women; 7% injection drug use). A substantial minority was on Medicaid (41%). Across sites, there was significant uptake in practices consistent with maximizing the HIV care workforce (18% increase, p < 0.001), share-the-care (25% increase, p < 0.001), and facilitating patient engagement in HIV primary care (13% increase, p < 0.001). There were also significant improvements over time in retention in HIV care (adjusted odds ratio [aOR] = 1.03; 95% confidence interval [CI] 1.02-1.04; p < 0.001), ART prescription levels (aOR = 1.01; 95% CI 1.00-1.01; p < 0.001), and viral suppression (aOR = 1.03; 95% CI 1.02-1.04; p < 0.001). All outcomes improved at sites that implemented transformations to maximize the HIV care workforce or improve client engagement. At sites that implemented share-the-care practices, only retention in care and viral suppression outcomes improved. Study limitations included use of demonstration project sites funded by the Ryan White HIV/AIDS Program (RWHAP), which tend to have better HIV outcomes than other US clinics; varying practice transformation designs; lack of a true control condition; and a potential Hawthorne effect because site teams were aware of the evaluation. CONCLUSIONS: In this study, we found that practice transformations are a potential strategy for addressing anticipated workforce challenges among those providing care to PLWH. They hold the promise of optimizing the use of personnel and ensuring the delivery of care to all in need while potentially enhancing HIV care continuum outcomes.

Implementation of a Community-Based Hybrid HIV Testing Services Program as a Strategy to Saturate Testing Coverage in Western Kenya.

BACKGROUND: Knowledge of HIV status is the entry point for linkage to prevention, care, and treatment, and the first step toward achieving the UNAIDS 90-90-90 targets. Most countries rely on proxies for estimating testing saturation, including periodic population-based sampling and yield (number positive among those tested). We conducted a community-based "Hybrid" HIV testing services (HTS) program to identify persons unaware of their HIV-positive status. SETTING: Homa Bay County, Kenya; July-September, 2016. METHODS: We conducted community mapping, household census, multi-disease community health campaigns (CHCs), and home-based tracking. HIV testing eligibility was based on 2015 national guidelines. The previously unidentified fraction (PUF) was defined as the proportion of newly identified persons living with HIV (PLWH) out of all previously identified and newly identified PLWH. RESULTS: The Hybrid HTS program reached 28,885 persons in total: 25,340 residents and 3545 nonresidents. There were 19,288 persons reached through CHCs and tracking. Of 11,316 individuals eligible for HIV testing, 9463 (83%) accepted testing, including 1230 (13%) first-time testers. There were 115 newly identified PLWH of 1589 total HIV-positive persons, representing a 7.2% PUF. Of 93 newly identified PLWH at the CHCs, 68% initiated same-day antiretroviral therapy. CONCLUSION: The Hybrid HTS program identified persons previously unaware of their HIV-positive status, thereby enabling linkage to care and same-day treatment and reducing onward transmission risk. An approach focused on identifying persons unaware of their HIV-positive status in combination with ascertaining the PUF has the potential to better target testing strategies to identify >90% of PLWH in a community.

Empowering HIV-infected women in low-resource settings: A pilot study evaluating a patient-centered HIV prevention strategy for reproduction in Kisumu, Kenya.

BACKGROUND: Female positive/male negative HIV-serodiscordant couples express a desire for children and may engage in condomless sex to become pregnant. Current guidelines recommend antiretroviral treatment in HIV-serodiscordant couples, yet HIV RNA viral suppression may not be routinely assessed or guaranteed and pre-exposure prophylaxis may not be readily available. Therefore, options for becoming pregnant while limiting HIV transmission should be offered and accessible to HIV-affected couples desiring children. METHODS: A prospective pilot study of female positive/male negative HIV-serodiscordant couples desiring children was conducted to evaluate the acceptability, feasibility, and effectiveness of timed vaginal insemination. Eligible women were 18-34 years with regular menses. Prior to timed vaginal insemination, couples were observed for two months, and tested and treated for sexually transmitted infections. Timed vaginal insemination was performed for up to six menstrual cycles. A fertility evaluation and HIV RNA viral load assessment was offered to couples who did not become pregnant. FINDINGS: Forty female positive/male negative HIV-serodiscordant couples were enrolled; 17 (42.5%) exited prior to timed vaginal insemination. Twenty-three couples (57.5%) were introduced to timed vaginal insemination; eight (34.8%) achieved pregnancy, and six live births resulted without a case of HIV transmission. Seven couples completed a fertility evaluation. Four women had no demonstrable tubal patency bilaterally; one male partner had decreased sperm motility. Five women had unilateral/bilateral tubal patency; and seven women had an HIV RNA viral load (≥ 400 copies/mL). CONCLUSION: Timed vaginal insemination is an acceptable, feasible, and effective method for attempting pregnancy. Given the desire for children and inadequate viral suppression, interventions to support safely becoming pregnant should be integrated into HIV prevention programs.

Integrating family planning and HIV services in western Kenya: the impact on HIV-infected patients' knowledge of family planning and male attitudes toward family planning.

Little information exists on the impact of integrating family planning (FP) services into HIV care and treatment on patients' familiarity with and attitudes toward FP. We conducted a cluster-randomized trial in 18 public HIV clinics with 12 randomized to integrated FP and HIV services and 6 to the standard referral-based system where patients are referred to an FP clinic. Serial cross-sectional surveys were done before (n = 488 women, 486 men) and after (n = 479 women, 481 men) the intervention to compare changes in familiarity with FP methods and attitudes toward FP between integrated and nonintegrated (NI) sites. We created an FP familiarity score based on the number of more effective FP methods patients could identify (score range: 0-6). Generalized estimating equations were used to control for clustering within sites. An increase in mean familiarity score between baseline (mean = 5.16) and post-intervention (mean = 5.46) occurred with an overall mean change of 0.26 (95% confidence intervals [CI] = 0.09, 0.45; p = 0.003) across all sites. At end line, there was no difference in increase of mean FP familiarity scores at intervention versus control sites (mean = 5.41 vs. 5.49, p = 0.94). We observed a relative decrease in the proportion of males agreeing that FP was "women's business" at integrated sites (baseline 42% to end line 30%; reduction of 12%) compared to males at NI sites (baseline 35% to end line 42%; increase of 7%; adjusted odds ration [aOR] = 0.43; 95% CI = 0.22, 0.85). Following FP-HIV integration, familiarity with FP methods increased but did not differ by study arm. Integration was associated with a decrease in negative attitudes toward FP among men.